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The Benefits of Clinical Trials

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Experts who know how clinical trials actually function are in disbelief that the American public views them negatively. Carolyn R. Aldige, president and founder of the Cancer Research Foundation of America, tells WebMD: "Anyone with a cancer that cannot be effectively treated should aggressively seek out participation in a clinical trial. The chances of receiving the latest and best treatment is so much higher."

Aldige's organization is sponsoring a national survey in hopes of gaining a better understanding of why people are reluctant to enroll in cancer trials. In cancer trials, she notes, patients always receive either the best standard treatment or an additional treatment that may be even more effective.

Aldige points out that clinical trials have a high degree of protection for patients. Every trial is approved by the FDA to assure that the product being tested will be safe, and by an institutional review board, consisting of experts at the institution where the trial is taking place. The review board, among other things, assures that patients receive the information they need to decide whether to participate.

A patient must sign an informed consent form to participate in a study. A good informed consent form will tell them what the therapy is for, whether all patients will receive an active drug, what the possible or expected benefits are, and what the risks may be.

During clinical studies, extensive information is gathered from the patients -- their disease or condition, how they react to the treatment, and potential side effects, which will be monitored.

The health sections of newspapers are filled with advertisements for clinical trials, for everything from sleep disorders to depression to high cholesterol to menopausal symptoms. Drug investigators must advertise to recruit patients with the exact criteria they are seeking. Increasingly, the Internet is being used for recruitment. The National Institutes of Health recently launched its own web page to list clinical trials and the medical criteria for entry: http://clinicaltrials.gov .

Aldige and other experts advise people with diseases that do not have fully effective treatments to explore -- through their physicians, newspapers, or the Internet -- the possibility of enrolling in clinical trials. Not only will these patients benefit, but the more people who enroll, the more quickly new therapies will become available for people who may need them in the future.

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